Job Title:  Process Development Associate (JP7813)
Location: Thousand Oaks, CA. (Onsite Essential)
Employment Type:  Contract
Business Unit: Potency and Characterization
Duration: 2+ years (with likely extensions)
Posting Date: 10/15/20
 
 
3 Key Consulting is hiring an Process Development Associate for a consulting engagement with our direct client, a leading global biopharmaceutical company.
 
Job Description:
This position is responsible for developing, qualifying, and transferring state-of-the-art and fit-for-purpose quantitative potency and characterization assays and supporting regulatory submissions.  Responsibilities include:

• Implementing state-of-the-art and fit-for-purpose analytical methods for: release testing, stability testing, product characterization/optimization, reference standard characterization, and investigations.
• Providing data to support technical reports for investigations, product and impurity characterization, and regulatory submissions.
• Generating and analyzing analytical data to support: product development investigations, and regulatory submissions.
• May contribute to critical analytical development teams (e.g., Product and process development teams, Product quality teams) by providing analytical updates, analytical documentation and data interpretation.
• Develops and enhances scientific and technical skills.
• Supporting analytical projects involving method development, qualification, and transfer.

 
Top Must-Have Skill Sets:

• Pipetting Skills.
• Binding and/or cell-based assay experience.
• Cell Culturing Experience.

 
Day to Day Responsibilities:

• Cell culture.
• Binding assay execution.
• Cell-based assay execution.

 
Basic Qualifications:

• Master’s degree: 1 years of pharma or biotech industry experience.
• Bachelor’s degree & 3 to 5 years of pharma or biotech industry experience.
• Must have Pipetting ,Binding and/or cell-based assay experience, Cell Culturing Experience.

 
Preferred Qualifications:

• Experience in cell culture and cell biology techniques for quantitative determination of biological activity of proteins.
• Experience in cell-based bioassay development (method characterization, qualification, validation, technical transfer).
• Experience with signal transduction, gene expression, receptor binding and fluorescent probe technologies.
• Experience in molecular biology techniques to manipulate plasmid constructs for generation of transfected stable cell lines.
• Detail oriented and excellent documentation skills preferred.
• Experience with automated liquid handling preferred.
• Innovation –supports new ideas and initiatives.
• Client orientation– establishes effective and responsive relationships with all clients.
• Communication and Interpersonal skills – communicate effectively with others, using appropriate diplomacy and sensitivity; makes others feel respected, valued and understood; works well in teams.

 
 
Employee Value Proposition:
Exciting opportunity to work on pipeline projects. Opportunity to work in a bio-assay industry leading lab.
 
 
Red Flags:

• Jumpy job history.
• Lack of top 3 skills.

 
Interview process:
Video Skype Panel Interview.
 
We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.